Sling vs No Sling After Reverse Total Shoulder Arthroplasty

Shoulder Osteoarthritis Clinical Trial

Official title:

Sling vs No Sling After Reverse Total Shoulder Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06092996
• Other study ID #: Pro00113901
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2023
• Est. completion date: December 2027

Study information

• Verified date: October 2023
• Source: Duke University
• Contact: Caroline Questell, BSN
• Phone: 919-613-3670
• Email: caroline.darragh[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study involves patients who will be undergoing a reverse total shoulder replacement at Duke University. 100 eligible will be randomly assigned into one of two groups, a sling or no sling group. Patients in the sling group will wear a sling for three weeks after their surgery while the no sling group will only wear a sling three days after their surgery. Patients will follow their doctors normal follow up visit schedule after surgery, with visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years.

Description:

The purpose of this study is to determine whether or not a sling is necessary after the nerve block has worn off postoperatively for patients undergoing reverse total shoulder arthroplasty. Patients who are scheduled for a reverse total shoulder with the participating investigators will be approached for potential participation in the study. Before the surgery, subjects will be randomly assigned to either the Sling (control) group or the No-Sling (investigational) group. The Sling, or control, group will wear a sling through 3 weeks postoperatively. The No Sling (investigational) group, will wear a sling either through 3 days postoperatively. Following surgery, patients will be followed at their standard of care visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after their surgical date. The investigators will collect data from these standard of care visits including PROs (including but not limited to ASES and SANE), Adverse events data, and physical exam data including range of motion. Patients will be followed through their two-year visit and then taken off study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patient is scheduled to undergo a primary reverse shoulder arthroplasty procedure
• Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy
• Patient meets indications for primary reverse shoulder arthroplasty for the following diagnosis
• Rotator cuff arthropathy
• Glenohumeral arthritis
• Patient is between 18-100 years old
• Patient is English speaking

Exclusion Criteria:

• A history of ipsilateral shoulder arthroplasty
• A history of shoulder septic arthritis
• A history of a proximal humeral fracture
• Chronic locked dislocation
• Rheumatoid arthritis
• Tumors
• Axillary nerve damage
• Non-functioning deltoid muscle
• Glenoid vault deficiency precluding baseplate fixation
• Infection and neuropathic joints
• Known or suspected non-compliance, drug or alcohol abuse
• Patients incapable of judgement or under tutelage
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc.
• The subject is related to investigator as family members, employees, or other dependent persons

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear Arthropathy
• Shoulder Disease
• Shoulder Osteoarthritis

Intervention

Other:
• Time of Sling Use
Standard sling worn for only three days post operatively

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who develop any kind of postoperative complication	Incidence of postoperative complications	Up to the first 2 years following surgery
Secondary	American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) score	The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. Total score ranges from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.	Up to the first 2 years following surgery
Secondary	Single Assessment Numeric Evaluation (SANE) score	The SANE is a single-question outcome measure that asks patients to rate their function (as it pertains to the area being treated) on a scale of 0 to 100, where a higher score indicates greater function.	Up to the first 2 years following surgery